ISPE launches plan to prevent drug shortages

ISPE, the International Society for Pharmaceutical Engineering, released its Drug Shortages Prevention Plan at its 2014 Annual Meeting in Las Vegas, Nevada. Regulators from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), have welcomed the Plan.

The Plan lays out how industry can best prevent drug shortages by identifying the root causes of supply disruptions and creating a quality culture that will ensure a robust, resilient and reliable supply of medications.

'ISPE's Drug Shortages Prevention Plan is part of a significant and continuing effort since 2011 to ensure a safe, quality and reliable drug supply,' said ISPE President and CEO John Bournas.

'We owe patients a sense of security by meeting their expectations for a reliable and continuous supply of the medications that are so important to them and their families. When members of the pharmaceutical industry discover and put to work the valuable insights included in the Plan, particularly those promising to strengthen the integrity of the supply chain and those describing how to place a greater emphasis on end-to-end quality, a real difference can be made in the lives of patients.'

We owe patients a sense of security by meeting their expectations for a reliable and continuous supply of the medications

The Plan builds on the results of ISPE's 2013 Drug Shortages Survey that cited manufacturing quality issues as a major cause of drug shortages. It is global in nature and represents a continuum of work done to date supporting the EMA, FDA, and ongoing communications with other health authorities, such as Health Canada and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

'In 2012, a drug shortage crisis developed in many parts of the world, including the US,' said Donna Gulbinski, Senior Vice President Global Quality and Environmental Health at Bristol- Meyers Squibb and member of the ISPE Task Team.

'We knew that quality manufacturing issues were a root cause, but drilling down further we found other elements, such as equipment, raw materials and facility manufacturing problems. The Plan recommends that firms build a corporate goal around product quality and make building a Corporate Quality Culture the responsibility of everyone, from the CEO to the shop floor.'

Firms should build a corporate goal around product quality and make building a Corporate Quality Culture the responsibility of everyone

The Plan represents a collective effort by pharmaceutical and biopharmaceutical industry experts. It has been reviewed by regulators from the EMA and US FDA, and by national competent authorities including the Spanish Agency of Medicines and Medical Devices (AEMPS) and the MHRA.

In creating the Plan, the Task Team engaged with more than 30 major pharmaceutical companies and included input from experts from several pharmaceutical associations, including the Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic Medicines Association (EGA), the Parenteral Drug Association (PDA), and the Plasma Protein Therapeutics Association (PPTA).

'Congratulations to ISPE,' said Douglas Throckmorton, Deputy Director, Regulatory Programs, FDA/CDER. 'Cooperation between industry and regulators is essential to preventing shortages before they occur, and the Plan highlights the value of cooperation for us to continue making progress in preventing drug shortages.'

ISPE organised the Plan around a 'six dimension' framework comprising: corporate quality culture; robust quality system; metrics; business continuity planning; communication with authorities; and building capability.

'We thank the members of industry and the Drug Shortages Task Team for their hard work and also thank regulators from the many agencies who played an advisory role,' added Bournas.

'The creation of this Plan has been a true team effort and one that will ultimately benefit not only the industry and regulators, but, most importantly, it also promises to have a great impact on the lives of patients.'

ISPE is providing the Drug Shortages Prevention Plan as a free downloadable PDF on its website.